Functional Connectivity After Anterior Cruciate Ligament Reconstruction

NCT05487768 | Completed

• 1 other identifier: ONZ-2022-0231
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Despite surgical reconstruction and rehabilitation, individuals after a primary anterior cruciate ligament injury have a significantly increased risk of relapse. The mechanisms for this increased risk may go beyond mere physiological and biomechanical changes of the reconstructed anterior cruciate ligament. The loss of ligamentous mechanoreceptors can affect sensory feedback and consequently result in a disrupted afferent input to the central nervous system. However, research on the neuroplasticity of the central nervous system after anterior cruciate ligament injury and more specifically on the cooperation between different brain areas (=functional connectivity) in motor execution and performance is limited. Research purpose: To investigate the changes in terms of functional connectivity in the brain after sustaining an anterior cruciate ligament injury and associated reconstruction? Population:

• Patients after anterior cruciate ligament reconstruction
• Healthy controls Protocol: First, all participants are required to complete several questionnaires regarding the level of anxiety and the functioning of the knee in daily activities and sports. In addition, during the baseline testing, participants will be required to perform an experiment while electrical brain activity is recorded by means of an electroencephalography (EEG) measurement. During this experiment, the participants will have to successively perform the following exercises: 10x knee extension from sitting (left and right), 10x bipodal squat from standing, 5x 30 seconds unipodal standing (left and right). The above protocol will be administered to the patient group for the first time 8 weeks after the anterior cruciate ligament reconstruction. When the patients do not need further rehabilitation, they will be invited a second time to execute the same protocol again. The control group will only have to carry out the above protocol once. Finally, for one year after the last test, the patient group will be contacted monthly to monitor return to sport and the occurrence of injuries.

Conditions

Anterior Cruciate Ligament Rupture; Electroencephalography; Injuries

Outcome Measures

Primary Outcomes (1)

• Change in functional connectivity in the brain in patients following anterior cruciate ligament reconstruction

  Electroencephalography (EEG) will be recorded from a 128 Sn surface electrode cap during 3 motor tasks. Functional connectivity will be analyzed.

  Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

Secondary Outcomes (6)

• Change in subjective knee functionality measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire

  Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

• Change in kinesiophobia measured by the Tampa scale of Kinesiophobia (TSK) - Questionnaire

  Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

• Change in knee confidence - Questionnaire

  Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

• Change in worrying behaviour measured by the Penn State Worry Questionnaire (PSWQ) - Questionnaire

  Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

• Change in athletes' emotion, confidence, and risk appraisal when returning to sports after an anterior cruciate ligament reconstruction measured by the ACL-Return to sport after injury (ACL-RSI) - Questionnaire

  Experimental group: 8 weeks postoperative and at the end of the rehabilitation (on average 9-12 months postoperative) / Control group: baseline

Study Arms (2)

Anterior cruciate ligament reconstruction group

EXPERIMENTAL

Patients that underwent an anterior cruciate ligament reconstruction

Other: EEG measurement

Control group

ACTIVE COMPARATOR

Healthy matched controls

Other: EEG measurement

Interventions

EEG measurement OTHER

EEG measurement to evaluate functional connectivity in the brain during 3 motor tasks: * Knee extension while sitting (10x left - right) * Bipodal squatting (10x) * Unipodal stance (5x30 seconds left-right)

Anterior cruciate ligament reconstruction group; Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Older than 18 years of age.
• Primary anterior cruciate ligament rupture and reconstruction

You may not qualify if:

• Major knee surgery in the past.
• Diagnosed with any knee pathology at this moment.
• Have any muscle or nerve related conditions that affect the functioning of the lower limbs.
• CONTROL GROUP
• \- Older than 18 years of age.
• Major knee surgery in the past.
• Diagnosed with any knee pathology at this moment.
• Have any muscle or nerve related conditions that affect the functioning of the lower limbs.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University, Department of Rehabilitation Sciences

Ghent, Belgium

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Wounds and Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries

Study Officials

• Erik Witvrouw, Prof. Dr.

  Department of Rehabilitation Sciences, Ghent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 4, 2022
• Study Start: September 23, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)